MBT CEM KEEL TIB TRAY SZ3
Received Jul 26, 2012 · Event occurred Nov 20, 2009
Report 1818910-2012-17897 · MDR key 2671596
Device
Product problems
- Loss of or Failure to Bond
Patient
44 YR
- Pain
- Swelling
Narrative
Description of Event or Problem
PATIENTS FATHER CONTACTED DEPUY. PATIENT HYPER-EXTENDED HER KNEE WHILE GETTING OUT OF THE SHOWER. PATIENT THEN HAD NUMBNESS TINGLING DOWN THROUGH HER TOES, UNSTABLE, AND TENDER TOUCH ON THE OUTSIDE OF THE KNEE CAP. MEDICAL RECORDS WERE RECEIVED AND TIBIAL LOOSENING WAS NOTED INTRA-OPERATIVELY. (LEFT KNEE).
Additional Manufacturer Narrative
THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED ANOMALIES. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.
Additional Manufacturer Narrative
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.